Apparatus and method for treating rhinitis

ABSTRACT

Devices and methods for treating rhinitis are described where the devices are configured to ablate a single nerve branch or multiple nerve branches of the posterior nasal nerves located within the nasal cavity. A surgical probe may be inserted into the sub-mucosal space of a lateral nasal wall and advanced towards a posterior nasal nerve associated with a middle nasal turbinate or an inferior nasal turbinate into a position proximate to the posterior nasal nerve where neuroablation of the posterior nasal nerve may be performed with the surgical probe. The probe device may utilize a visible light beacon that provides trans-illumination of the sub-mucosal tissue or an expandable structure disposed in the vicinity of the distal end of the probe shaft to enable the surgeon to visualize the sub-mucosal position of the distal end of the surgical probe from inside the nasal cavity using, e.g., an endoscope.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Continuation of U.S. application Ser. No.14/808,690 filed Jul. 24, 2015, which claims the benefit of U.S.Provisional Application Ser. No. 62/028,995 filed Jul. 25, 2014, theentire contents of which are incorporated herein by reference in theirentirety for all purposes.

FIELD OF THE INVENTION

The present invention relates to cryosurgical probes and their methodsof use. More particularly, the present invention relates to cryosurgicalprobes which are configured to be advanced into a nasal cavity fortreating conditions such as rhinitis.

BACKGROUND OF THE INVENTION

The major symptoms of allergic or non-allergic chronic rhinitis aresneezing, rhinorrhea, and night time coughing which are brought about bymucosal swelling, hyper-responsiveness of the sensory nerves, and anincreased number and augmented responses of secretory cells in theinferior turbinates, respectively. In particular, chronic severe nasalobstruction resulting from remodeling of submucosal tissues of theinferior turbinates due to dilation of the venous sinuses or fibrosiscan interfere with the quality of life (QOL).

One strategy is the surgical treatment of chronic rhinitis; that is tophysically eliminate the tissue of the inferior turbinate. Removal orablation of the mucosal tissue including the surface epithelial layerhas the disadvantage of postoperative complications such as crusting andan increased infection rate. Cauterization of the surface epithelia ofthe inferior turbinate using electrocautery, cryosurgery, or laseryields only short-term benefits to nasal breathing. Submucosal diathermyor cryosurgery also shows only a short-term effect. Turbinectomy isthought to have the greatest effect on nasal obstruction, and slightimprovement in some rhinitis patients but it is accompanied by severeadverse effects such as bleeding, crusting, and nasal dryness.

Golding-Wood, who recommended cutting the parasympathetic nerve fibersin the vidian canal to decrease the parasympathetic tone to the nasalmucosa, introduced a different approach for the treatment ofhypersecretion in 1961. Various approaches to the vidian canal weresubsequently developed, and the method was widely employed in the 1970s.However, the original technique was abandoned at the beginning of the1980s because of its irreversible complications such as dry eyes.

The pterygoid canal carries both parasympathetic and sympathetic fibers,namely the vidian nerve, to the sphenopalatine ganglion. Subsequently,these autonomic fibers, which relay in the sphenopalatine ganglion,reach the nasal mucosa through the sphenopalatine foramen as theposterior nasal nerve. Resection of the posterior nasal nerve has theeffect of both parasympathetic and sympathetic resection in the nasalmucosa, similar to vidian neurectomy. In addition, this procedure, inwhich somatic afferent innervation to the nasal mucosa is alsointerrupted, can be expected to reduce the hypersensitivity and axonreflexes of the nasal mucosa. The posterior nasal nerve, which followsthe sphenopalatine artery and vein, arises within the sphenopalatineforamen and can be easily identified. Furthermore, selectiveinterruption of the posterior nasal nerves has no complications, likethose of vidian neurectomy, since the secretomotor supply to thelacrimal gland and the somatosensory supply to the palate are intact,and overpenetration of the pterygoid canal does not occur.

Posterior nasal neurectomy, initially developed by Kikawada in 1998 andlater modified by Kawamura and Kubo, is a novel alternative method inwhich neural bundles are selectively cut or cauterized from thesphenopalatine foramen. Autonomic and sensory nerve fibers that passthrough the foramen anatomically branch into the inferior turbinate andare distributed around the mucosal layer. Therefore, selectiveneurectomy at this point enables physicians to theoretically avoidsurgical complications such as inhibition of lacrimal secretion.

SUMMARY OF THE INVENTION

There are three nerve bundles innervating the superior, middle andinferior turbinates. The posterior, superior lateral nasal branches offof the maxillary nerve (v2) innervate the middle and superiorturbinates. A branch of the greater palatine nerve innervates theinferior turbinate. Ablating these nerves leads to a decrease in orinterruption of parasympathetic nerve signals that contribute torhinorrhea in patients with allergic or vasomotor rhinitis. The devicesand methods described herein are configured for ablating one or more ofthese three branches to reduce or eliminate rhinitis.

The following is the description of the embodiments that achieve theobjectives of ablating the Posterior Nasal Nerves (PNN). Any of theablation devices can be used to ablate a single nerve branch or multiplenerve branches.

In accordance with one aspect of this invention is a method for treatingrhinitis comprising inserting the distal end of a surgical probe intothe sub-mucosal space of a lateral nasal wall, then advancing the distalend towards a posterior nasal nerve associated with a middle nasalturbinate or an inferior nasal turbinate into a position proximate tothe posterior nasal nerve, then performing neuroablation of theposterior nasal nerve with the surgical probe.

One embodiment of the surgical probe may be configured for sub-mucosalneuroablation of a posterior nasal nerve associated with a middle nasalturbinate, or an inferior nasal turbinate and may generally comprise asurgical probe shaft comprising an elongated hollow structure with adistal end and a proximal end, wherein the surgical probe shaft is sizedfor insertion into and advancement within a sub-mucosal space of alateral nasal wall from within a nasal cavity; a handle coupled to theproximal end; a neuroablation agent delivery mechanism disposed on thedistal end; and an optical beacon disposed in a vicinity of the distalend, wherein the optical beacon provides an indication of a position ofthe distal end within the nasal cavity when visualized.

In use, one embodiment for a method of treating rhinitis may generallycomprise inserting the distal end of the surgical probe into thesub-mucosal space of a lateral nasal wall located within the nasalcavity, the surgical probe comprising the surgical probe shaft with thedistal end and the proximal end, the handle coupled to the proximal end,the neuroablation agent delivery mechanism disposed on the distal end,and the optical beacon disposed in the vicinity of the distal end;visualizing a cul de sac defined by a tail of a middle nasal turbinate,lateral wall, and inferior nasal turbinate within the nasal cavity;advancing the distal end towards the cul de sac and into proximity ofthe posterior nasal nerve associated with a middle nasal turbinate or aninferior nasal turbinate while visually tracking a position of thedistal end by trans-illumination of the optical beacon through mucosa;and performing neuroablation of the posterior nasal nerve.

The surgical probe comprises a probe shaft with a distal end and aproximal end. A surgical hand piece is disposed in the vicinity of theproximal end, and a neuroablation implement is disposed in the vicinityof the distal end. The surgical probe shaft may be configured with anendoscopic visualization aid disposed in the vicinity of the distal endthat allows the surgeon to determine the sub-mucosal position of thedistal end by endoscopic observation of the lateral nasal wall frominside of the associated nasal cavity.

In one embodiment of the method the endoscopic visualization aid is avisible light beacon that provides trans-illumination of the sub-mucosaltissue allowing the surgeon to visualize the sub-mucosal position of thedistal end of the surgical probe from inside the associated nasal cavityusing an endoscope. The light beacon may be configured to emit lightthat is within the green segment of the visible optical spectrum. Thegreen segment of the visible optical spectrum is absorbed strongly byhemoglobin and absorbed weakly by connective tissues. The targetposterior nasal nerve(s) is co-sheathed with an associated artery andvein. The arrangement of having the nerve, artery and vein that arerelated to the same anatomical function is common in mammalian anatomy.Since the green light is strongly absorbed by both the arterial andvenous hemoglobin, the visible trans-illumination from the light beaconwill be dimmed when the light beacon is positioned immediately proximateto the sheath comprising the target posterior nasal nerve, due toabsorption of the green light by the blood flowing through theassociated artery and vein. This provides a means for locating thetarget posterior nasal nerve by locating its associated artery and vein.

The endoscopic visualization aid may comprise an expandable structuredisposed in the vicinity of the distal end of the surgical probe shaft.The expandable structure is configured with a user operated inflationand deflation device. The surgical probe may be inserted into thesub-mucosal space in with the expandable structure in an un-expandedstate, then advanced towards the target posterior nasal nerve. When thesurgeon needs to determine the position of the distal end of thesurgical probe, the expandable structure is expanded by the surgeondisplacing the overlying mucosal tissue, which is visible by endoscopicobservation from within the nasal cavity providing the surgeon anindication of the location of the distal end of the surgical. Thesurgical probe comprises a device for the user to inflate and deflatethe expandable structure, which is disposed on the surgical hand piece.The expandable structure may also be used to help advance the distal endof the surgical probe by using the expandable structure to create ablunt dissection through the surgical plane defined by the bone of thenasal wall and the overlying mucosa.

The neuroablation device may comprise a tissue heating mechanism, or atissue freezing mechanism, or may comprise the sub-mucosal delivery of aneurolytic solution to the vicinity immediately proximate to the targetposterior nasal nerve. Regardless of the neuroablation mechanism, themethod is conceived such that collateral damage to adjacent vitalstructures is avoided by limiting the zone of therapeutic effect to theimmediate vicinity of the target posterior nasal nerve. The minimizationof collateral damage is facilitated by the visualization aided accurateplacement of the distal neuroablation implement in the immediateproximity of the target posterior nasal nerve, and precise control ofthe neuroablation parameters.

In one embodiment of the method a surgical probe is used that isconfigured for neuroablation by tissue heating comprising at least oneradio frequency (RF) electrode disposed in the vicinity of the distalend of the surgical probe shaft. The RF electrode(s) is connected to onepole of an RF energy generator. Alternatively, at least two electrodesmay be disposed in the vicinity of the distal end with at least oneelectrode connected to one pole of an RF energy generator, and at leastone additional electrode connected to the second pole of the RF energygenerator. The RF energy generator may reside within the surgical handpiece, and the wire(s) connecting the RF electrode(s) to the RF energygenerator may reside within the surgical probe shaft. The RF energygenerator and the RF electrodes may be configured to heat tissue by,e.g., Ohmic resistance effect, in a manner intended to limit the volumetissue that is heated to the target zone that is immediately proximateto the posterior nasal nerve. The surgical probe may be configured foruser selection of the neuroablation operating parameters including RFpower, RF current, target tissue temperature, and heating time.

In another embodiment of the method a surgical probe is used that isconfigured for heating comprising an ultrasonic energy emittingtransducer connected to an ultrasonic energy generator. The ultrasonicenergy transducer is configured to heat tissue in a manner that limitsthe heating effect to the volume of tissue immediately proximate to thetarget posterior nasal nerve. The surgical probe may be configured foruser selection of neuroablation parameters including ultrasonic energyfrequency, power, target tissue temperature, and heating time. Theultrasonic generator may be disposed within the hand piece, and thewire(s) connecting the ultrasonic transducer to the ultrasonic energytransducer may reside within the surgical probe shaft. The surgicalprobe may be configured where the ultrasonic transducer provides Dopplerblood flow sensing in addition to tissue heating. Ultrasonic dopplerblood flow sensing can be used to sense arterial or venous blood flowthat is in close proximity to the ultrasonic transducer, which allowsthe surgeon to avoid damage to an artery or a vein with the surgicalprobe, or to find a target posterior nasal nerve by sensing the bloodflow through the artery or vein associated with the posterior nasalnerve.

In an alternative embodiment of the method a surgical probe is used thatis configured for tissue heating comprising an optical energy tissueheating mechanism. An optical energy generator may be disposed withinthe surgical hand piece, and an optical fiber may transmit the opticalenergy from the optical energy generator to the distal end of thesurgical probe shaft into the proximate distal tissue. The opticalenergy generator may be a laser diode. The surgical probe may beconfigured with user selectable neuroablation parameters includingoptical power, optical wavelength(s), pulse width and frequency, andtime of heating. The surgical probe may be configured with more than oneoptical energy generator where one optical energy generator isconfigured for tissue heating, and a second optical energy generator isconfigured for providing visible light for a distal optical beacon thatfunctions as an endoscopic visualization aid by means oftrans-illumination of the nasal mucosa, allowing the distal end of thesurgical probe to be visualized from inside the nasal cavity bytrans-illumination through the overlying mucosal tissue. A singleoptical transmission fiber may be configured for tissue heating, and forproviding a distal optical beacon.

One embodiment of the method comprises the use of a surgical probeconfigured for tissue freezing. The surgical probe comprises a liquidcryogen evaporation chamber disposed in the vicinity of the distal end,and a liquid cryogen reservoir disposed within the surgical hand piece.A liquid cryogen conduit is disposed within the surgical probe shaftbetween the liquid cryogen evaporation chamber and the liquid cryogenreservoir. The liquid cryogen evaporation chamber may comprises a rigidmetallic structure, or may comprise an expandable structure. Theexpandable structure may be configured as a liquid cryogen evaporationchamber, and as an endoscopic visualization aid. The expandablestructure may be configured to expand in response to liquid cryogenevaporation, and may be configured for expansion independently of liquidcryogen evaporation. The surgical probe may be inserted into thesub-mucosal space with the expandable structure in an un-expanded state,then advanced towards the target posterior nasal nerve. When the surgeonneeds to determine the position of the distal end of the surgical probe,the expandable structure is expanded by the surgeon displacing theoverlying mucosal tissue, which is visible by endoscopic observationfrom within the nasal cavity providing the surgeon an indication of thelocation of the distal end of the surgical probe shaft. The surgicalprobe comprises a mechanism for the user to inflate and deflate theexpandable structure, which is disposed on the surgical hand piece. Theexpandable structure may also be used to help advance the distal end ofthe surgical probe by using the expandable structure to create a bluntdissection through the surgical plane defined by the bone of the nasalwall and the overlying mucosa. A surgical probe comprising a cryogenliquid evaporation chamber that is a rigid metallic structure may alsobe configured with an expandable structure configured for inflation anddeflation by the user which is configured as an endoscopic visualizationaid, and for blunt dissection as described above. Alternatively to thecryogen evaporation chamber comprising a rigid metallic structure, atissue freezing element may comprise, e.g., a Joule-Thompson effecttissue freezing mechanism, and be within the scope of this invention.

In one embodiment of the method a surgical probe is used that isconfigured for neuroablation of target posterior nasal nerve(s) bysub-mucosal delivery of a neurolytic solution immediately proximate tothe target posterior nasal nerve(s). The neurolytic solution may be aneurotoxic agent, a parasympatholytic agent, or a sclerosing agent. Aneurotoxic agent may be botulinum toxin, β-Bunarotoxin, tetnus toxin,α-Latrotoxin or another neurotoxin. A sympatholytic agent may beGuanethidine, Guanacline, Bretylium Tosylate, or another sympatholyticagent. A sclerosing agent may be ethanol, phenol, a hypertonic solutionor another sclerosing agent. The surgical probe comprises a reservoir ofneurolytic solution disposed upon the surgical hand piece. A liquidconduit is disposed within the surgical probe shaft between thereservoir of neurolytic solution and the distal end of the surgicalprobe shaft. A mechanism to inject the neurolytic solution into thesub-mucosal tissue immediately proximate to the target posterior nasalnerve in a controlled manner is also disposed on the surgical handpiece. The liquid neuroablation reservoir and the means to controlinjection may comprise a syringe filled with a neurolytic solution. Anendoscopic visualization aid is disposed in the vicinity of the distalend of the surgical probe shaft.

The insertion of the distal end of the surgical probe into thesub-mucosal space of a lateral nasal wall may be done at a location thatis anterior to the middle nasal turbinate or the inferior nasalturbinate. The anterior insertion location is more accessible thanlocations that are more posterior for both the endoscopic imaging andsurgical probe manipulation. After insertion of the distal end of thesurgical probe into the sub-mucosal space, the distal end of thesurgical probe is advanced towards the target posterior nasal nervealong the surgical plane defined by the bone of the lateral nasal walland the overlying mucosal tissue. The surgical probe is advanced underone or both of the middle nasal turbinate and inferior nasal turbinate.The endoscopic visualization aid is used to provide the surgeon with theposition of the distal end of the surgical probe shaft during theadvancement. An alternative location for insertion of the distal end ofthe surgical probe shaft into the sub-mucosal space is in between themiddle turbinate and the inferior turbinate. This location is closer tothe target posterior nasal nerve(s), therefore there is a reduced lengthof blunt dissection during probe advancement towards the targetposterior nasal nerve(s), however, the access to the sub-mucosal spaceis more difficult, and may require surgical lateralization of one orboth of the middle nasal turbinate and inferior nasal turbinate. Thedistal end of the surgical probe shaft may also be inserted into thesub-mucosal space in the immediate vicinity of the cul de sac defined bythe tail of the middle turbinate, the lateral wall and in the inferiornasal turbinate.

The embodiments of the method that utilize tissue heating or tissuefreezing as a neuroablation means may further comprise protecting thesuperficial mucosa proximate to the target posterior nasal nerve(s) frominjury as a result of the sub-mucosal neuroablation. In the embodimentsof the method that utilize tissue heating as a neuroablation means, thesuperficial mucosa may be cooled during the neuroablation procedure toprevent the temperature of the superficial mucosal from exceeding atissue heating injury threshold. In the embodiments of the method thatutilize tissue freezing as a neuroablation means, the superficial mucosamay be warmed during the neuroablation procedure to prevent thetemperature of the superficial mucosa from exceeding a freezing tissueinjury threshold. The superficial mucosa may be warmed or cooled usingwarm or cold saline irrigation of the surface of the superficial mucosa.Also a balloon with a circulating warm or cold liquid may be pressedagainst the lateral nasal wall proximate to the target posterior nasalnerve during the neuroablation procedure to protect the superficialmucosa from thermal injury. Protecting the superficial mucosa fromthermal injury resulting from sub-mucosal neuroablation will reducecrusting, pain and inflammation following the procedure, speed therecovery period, and prevent infection of the nasal mucosa.

In another aspect of this invention is a surgical probe configured forsub-mucosal neuroablation of a posterior nasal nerve associated with amiddle nasal turbinate or an inferior nasal turbinate. The surgicalprobe comprises a surgical probe shaft that is an elongated hollowstructure with a distal end and proximal end. A surgical hand piece isdisposed on the proximal end of the surgical probe shaft. Aneuroablation implement is disposed at the distal end of the surgicalprobe shaft. An endoscopic visualization aid is disposed on the surgicalprobe shaft in the vicinity of the distal end. The surgical probe isconfigured for the distal end to be inserted into the sub-mucosal spaceof a lateral nasal wall from inside of a nasal cavity, and to beadvanced to a position proximate to a target posterior nasal nerve alongthe surgical plane defined by the bone of the lateral nasal wall and theoverlying mucosa, while visualizing the advancement from within theassociated nasal cavity using an endoscope and the endoscopicvisualization aid. The endoscopic visualization aid may be a visiblelight beacon comprising visible light. The visible light may beconfigured to be in the green segment of the visible light spectrum. Thebrightness of the visible light beacon may be adjustable, and theadjustment means may be disposed on the surgical hand piece.Alternatively, the endoscopic visualization aid may comprise anexpandable structure that is configured for inflation and deflation bythe surgeon. The expandable structure is configured to displace theoverlying mucosal tissue in a manner that is visually detectable byendoscopic observation of the surface of the lateral nasal mucosa fromwithin the nasal cavity. The endoscopic visualization aid may alsocomprise a bulbous structure that is non-expandable, that is configuredto be visually detectable by endoscopic observation. The neuroablationimplement may comprise a tissue heating mechanism, a tissue freezingmechanism or the distal delivery of a neurolytic solution proximate to atarget nasal nerve.

The tissue heating mechanism may comprise the delivery of optical energyproximate to the posterior nasal nerve. The optical energy source may bedisposed within the surgical hand piece, which may comprise at least onelaser diode. The optical energy may be delivered to the tissue proximateto the posterior nasal nerve by an optical transmission fiber disposedbetween the optical energy source and the distal end of the surgicalprobe shaft. The optical energy may be substantially in the red and/ornear infrared part of the optical spectrum, with an optical power levelbetween approximately, e.g., 0.2 watts and 2.0 watts. The surgicalprobe's endoscopic visualization aid may be in the form of an opticalbeacon, and may comprise light substantially in the green part of theoptical spectrum. The surgical hand piece may be configured with twooptical energy sources; one configured for tissue heating, and a secondconfigured for use with the optical beacon. Optical energy from bothoptical energy sources may be delivered to the distal end of thesurgical probe shaft by a common optical transmission fiber. The opticaltransmission fiber may comprise an optical transmission fiber bundle.

The tissue heating mechanism may comprise at least one electrodedisposed on the distal end connected to a pole of a radio frequency (RF)energy generator. The RF energy generator may be disposed within thesurgical hand piece. The tissue heating mechanism may comprise at leastone ultrasonic energy emitting transducer disposed on the distal end ofthe surgical probe shaft connected to an ultrasonic energy generator.The ultrasonic energy generator may be disposed within the surgical handpiece. The tissue heating means may comprise a microwave energy emittingantenna disposed on the distal end connected to a microwave energygenerator. The microwave generator may be disposed within the surgicalhand piece. The tissue heating mechanism may also comprise a hot contactsurface disposed at the distal end. The hot contact surface may beresistively heated by connection to an electrical power source. Theelectrical power source may be disposed within the surgical hand piece.

The surgical probe may be configured with a tissue freezing mechanismcomprising a liquid cryogen evaporation chamber disposed on the distalend of the surgical probe shaft. A reservoir comprising liquid cryogenmay be disposed within the surgical hand piece, as well as a useractivated liquid cryogen control valve. At least one liquid cryogenconduit is disposed between the liquid cryogen evaporation chamber andthe liquid cryogen reservoir and liquid cryogen flow control valvedisposed within the surgical probe shaft. The liquid cryogen evaporationchamber may comprise a hollow metallic chamber that is substantiallyrigid. Alternatively, the liquid cryogen evaporation chamber maycomprise an expandable structure that is configured for expansion inresponse to liquid cryogen evaporation. The expandable structure may beconfigured as a tissue freezing mechanism and an endoscopicvisualization aid. The expandable structure may be configured for useroperated inflation and deflation by a mechanism in addition to expansionin response to liquid cryogen evaporation.

The surgical probe may be configured to deliver a neurolytic solutioninto the sub-mucosal tissue immediately proximate to the targetposterior nasal nerve. The surgical probe may be configured with areservoir comprising a neurolytic solution. The reservoir may bedisposed upon the surgical hand piece. The surgical hand piece may beconfigured with a means for distal delivery of the neurolytic solutionin a highly controlled manner. The neurolytic solution may comprise aneurotoxic agent, a sympatholytic agent, or a sclerosing agent. Aneurotoxic agent may be botulinum toxin, β-Bunarotoxin, tetnus toxin,α-Latrotoxin or another neurotoxin. A sympatholytic agent may beGuanethidine, Guanacline, Bretylium Tosylate, or another sympatholyticagent. A sclerosing agent may be ethanol, phenol, a hypertonic solutionor another sclerosing agent.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an internal lateral view of the nasal canal showing the nasalanatomy relevant to this invention, and the targeted region of thelateral nasal wall for neuroablation of posterior nasal nerve function.

FIGS. 2A and 2B are schematic illustrations of a surgical probeconfigured for sub-mucosal neuroablation of a posterior nasal nervecomprising an optical beacon that functions as an endoscopicvisualization aid.

FIG. 3A is a schematic illustration of a surgical probe configured forsub-mucosal neuroablation of a posterior nasal nerve comprising anexpandable structure configured as an endoscopic visualization aid withthe expandable structure in its unexpanded state.

FIG. 3B is a schematic illustration of a surgical probe configured forsub-mucosal neuroablation of a posterior nasal nerve comprising anexpandable structure configured as an endoscopic visualization aid withthe expandable structure in its expanded state.

FIG. 4A is a cross sectional schematic illustration of the distal end ofa surgical probe comprising an expandable structure configured as anexpandable structure in a sub-mucosal position in the surgical planedefined by the bone of the lateral nasal wall and the overlying mucosal,with the expandable structure in its unexpanded state.

FIG. 4B is a cross sectional schematic illustration of the distal end ofa surgical probe comprising an expandable structure configured in asub-mucosal position in the surgical plane defined by the bone of thelateral nasal wall and the overlying mucosal with the expandablestructure in its expanded state.

FIG. 5A is a cross section schematic illustration of the surgical probeshaft with the distal end partially inserted into the sub mucosal space.

FIG. 5B is a cross section schematic illustration of the surgical probeshaft being advanced towards the target posterior nasal nerve along thesurgical plane defined by the bone of the lateral nasal wall and theoverlying mucosa.

FIG. 5C is a cross sectional illustration of the surgical probe shaftwith its distal end positioned proximate to the target posterior nasalnerve.

FIG. 5D is a cross section schematic illustration of the surgical probeshaft with the distal end coiled within the sub mucosal space.

FIG. 5E is a top view of the coiled distal end of the shaft shown inFIG. 5D.

FIG. 6A is a schematic illustration of the distal end of a sub-mucosalneuroablation probe configured for tissue freezing.

FIG. 6B is a cross section schematic illustration of the sub-mucosalneuroablation probe of FIG. 6A.

FIG. 7A is a schematic illustration of the distal end of a sub-mucosalneuroablation probe configured for tissue heating by means of a bipolarradiofrequency (RF) energy electrode pair.

FIG. 7B is schematic end-view illustration of the sub-mucosalneuroablation probe of FIG. 7A.

FIG. 8A is a schematic illustration of a sub-mucosal neuroablation probeconfigured for sub-mucosal delivery of a neurolytic solution.

FIG. 8B is a schematic end-view illustration of the sub-mucosalneuroablation probe of FIG. 8A.

FIG. 9 is a cross sectional schematic illustration of a sub-mucosalneuroablation probe configured for tissue freezing using an expandablestructure as a cryogen evaporation chamber, which also functions as anendoscopic visualization aid.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 depicts an internal view of the nasal cavity showing the nasalanatomy relevant to this invention. Shown for orientation is the lateralnasal wall 14, the nose 1, nostril 2, upper lip 3, sphenopalatineforamen 4, superior nasal turbinate 5, middle nasal turbinate 6,inferior nasal turbinate 7, postnasal nerve 8, greater palatine nerve 9,posterior nerve inferior lateral branch 10, posterior nerve middlelateral branch 11, posterior nerve superior inferior nasal branch 12,and cul de sac 13 defined by the tail of the middle nasal turbinate 6,lateral wall 14, and the inferior turbinate 7. Posterior nasal nerve 8is within a sheath comprising the sphenopalatine artery and vein, notshown. Posterior nasal nerve branches 10, 11, and 12 are co-sheathedwith the corresponding branches of the sphenopalatine artery and vein.Posterior nasal nerve 8 rises through the sphenopalatine foramen 4 alongwith the sphenopalatine artery and vein and remain, along with itsbranches 10, 11, and 12 between approximately 1 mm to 4 mm below thesurface of the nasal mucosa. The posterior nasal nerve 8 or its branches10, 11 and 12 are targets for sub-mucosal functional neuroablation forthe treatment of rhinitis according to this invention.

FIG. 2A is a schematic illustration of sub-mucosal neuroablation probe15. Sub-mucosal neuroablation probe 15 is a generic representation ofmultiple embodiments of this invention. Sub-mucosal neuroablation probe15 comprises surgical probe shaft 16, and surgical hand piece 17.Surgical probe shaft 16 is a hollow elongated structure with a distalend 18, and a proximal end 19. Surgical hand piece 17 is disposed at theproximal end 19 of surgical probe shaft 16. Surgical probe shaft 16comprises rigid segment 23, which is proximal to flexible segment 22. Aneuroablation implement 21 is disposed near the distal end of flexiblesegment 22, as shown. Associated with the neuroablation implement 21 isoptical beacon 20. Neuroablation implement 21 may be configured forsub-mucosal neuroablation by at least one of the following neuroablationmechanisms: neuroablation by tissue freezing mechanism, neuroablation bytissue heating and coagulation mechanism, or neuroablation bysub-mucosal delivery of a neurolytic solution. The neurolytic solutionmay comprise a neurotoxic agent, a sympatholytic agent, or a sclerosingagent. A neurotoxic agent may be botulinum toxin, β-Bunarotoxin, tetnustoxin, α-Latrotoxin or another neurotoxin. A sympatholytic agent may beGuanethidine, Guanacline, Bretylium Tosylate, or another sympatholyticagent. A sclerosing agent may be ethanol, phenol, a hypertonic solutionor another sclerosing agent. For embodiments of the invention that usetissue freezing as a neuroablation means, neuroablation implement 21represents a liquid cryogen evaporation chamber, or a gas expansionchamber configured with a Joule-Thompson mechanism. For embodiments thatutilize tissue heating and coagulation as a neuroablation mechanism,implement 21 may represent a radiofrequency (RF) energy heating element,a microwave energy heating element, an ultrasonic energy heatingelement, optical energy heating element, or resistive heating element.For embodiments of the invention that utilize sub-mucosal delivery of aneurolytic solution, neuroablation implement 21 may comprise a distalaperture of a fluid channel configured for sub-mucosal delivery of aneurolytic solution.

Surgical hand piece 17 comprises pistol grip 26, optical beaconbrightness control knob 24, neuroablation actuator trigger 25,neuroablation parameter(1) control knob 27, neuroablation parameter(2)control knob 28, finger grip 29, finger barrel 31, and neuroablationactuator button 32. Surgical hand piece 17 may be configured to be heldlike a piston by the surgeon using pistol grip 26, or the surgeon mayhold surgical hand piece 17 like a writing utensil using finger grips29, with finger grip barrel 31 residing between the thumb and indexfinger of the surgeon. Surgical hand piece 17 may be configured withneuroablation actuators comprising pistol trigger neuroablation actuator25, which may be used to actuate and terminate a neuroablation when thesurgeon holds the surgical probe 15 using pistol grip 19. Neuroablationactuator button 32 may be used to actuate and terminate a neuroablationwhen the surgeon holds surgical probe 15 by finger grips 29.

For embodiments of the invention that utilize tissue freezing as aneuroablation mechanism, surgical hand piece 17 may comprise a liquidcryogen reservoir, not shown, that may be supplied from the factory withliquid cryogen and configured for a single patient use. Alternatively,surgical hand piece 17 may be configured for use with a user replaceableliquid cryogen reservoir in the form of a cartridge. Liquid cryogencartridges are readily commercially available from many sources.Neuroablation actuator trigger 25, and neuroablation actuator button 32may be configured as cryogen control actuators. Neuroablationparameter(1) control knob 27 and neuroablation parameter(2) control knobmay be configured to control at least one of the following neuroablationparameter: Cryogen flow rate, cryogen flow time, tissue set pointtemperature, evaporation set point temperature, or an active re-warmingtemperature or power.

For embodiments of the invention that utilize tissue heating andcoagulation as a neuroablation mechanism, hand piece 17 may comprise anenergy generator disposed within, which may be an RF energy generator, amicrowave energy generator, an ultrasonic energy generator, an opticalenergy generator, or an energy generator configured for resistiveheating. Neuroablation actuator trigger 25 and neuroablation actuatorbutton 32 may be configured to turn an energy generator on and off.Neuroablation parameter(1) control knob 27, and neuroablationparameter(2) control knob 28 may be configured to control at least oneof the following neuroablation parameters: a set point tissuetemperature, a heating power, a heating current, a heating voltage, or aheating time.

There are embodiments where neuroablation actuator trigger 25,neuroablation actuator button 32, neuroablation parameter(1) controlknob 27, or neuroablation parameter(2) control knob 28 may be absent.Embodiments that utilize sub-mucosal delivery of a neurolytic solutionmay not utilize these features.

Optical beacon 20 is configured as an endoscopic visualization aid.Optical beacon 20 provides trans-illumination of the nasal mucosa andprovides the surgeon with an endoscopic determination of the exactposition of neuroablation implement 21 within the sub-mucosal space byendoscopic imaging of the surface of the mucosa of the lateral nasalwall. Surgical hand piece 17 comprises a light source, not shown,configured for supplying distal optical beacon 20 light via an opticaltransmission fiber disposed within probe shaft 16 between the lightsource and the distal optical beacon 20. Optical beacon brightnesscontrol knob 24 is configured for controlling the brightness of opticalbeacon 24. The light source may be configured to emit light that is inthe green segment of the visible optical spectrum, which is stronglyabsorbed by hemoglobin, and weakly absorbed by connective tissue. Theoptical beacon is configured for trans-illumination of the nasal mucosa,which is endoscopically observed from inside of the nasal cavity, whichprovides a visual mechanism for locating the neuroablation implement 21.When optical beacon 20 is placed in close proximity to thesphenopalatine artery and vein, which are co-sheathed the targetposterior nasal nerve, the hemoglobin within the artery and veinstrongly absorb the green light from optical beacon 20 resulting in anobservable dimming of the mucosal trans-illumination.

FIG. 2B is a schematic illustration of surgical probe shaft 16 taken atsection “A-A” from FIG. 2A. Surgical probe shaft 16 is betweenapproximately, e.g., 1 mm and 4 mm in diameter, and betweenapproximately, e.g., 4 cm and 10 cm in length. The rigid segment 23 ofsurgical probe shaft 16 may be fabricated from a surgical gradestainless steel hypodermic tube, or may alternatively be fabricated froma polymeric extrusion. Flexible segment 22 of probe shaft 16 may befabricated as a flat metal wire coil, or may be fabricated as a metalwire reinforced polymeric extrusion. Flexible segment 22 is configuredto provide sufficient column strength to transverse the mucosa duringinsertion into the sub-mucosal space, and to be flexible enough tofollow the surgical plane defined by the bone of the lateral nasal walland the mucosa as the distal end 18 is advanced towards the targetposterior nasal nerve 8, or its branches 10, 11, or 12. Flexible segment22 may have a higher flexibility in one lateral direction than anotherto facilitate “steering” through the sub-mucosal space. The length offlexible segment 23 may be approximately 30% to 70% of the length ofsurgical probe shaft 16. Those skilled in the art of flexible surgicalprobe shafts are familiar with mechanisms for producing a surgical probeshaft with the characteristics disclosed here within; therefore nofurther description is warranted.

FIG. 3A is a schematic illustration of sub-mucosal neuroablation probe35. Sub-mucosal neuroablation probe 35 is an alternative embodiment tosub-mucosal neuroablation probe 15 and uses an expandable structure 40as an endoscopic visualization aid in lieu of an optical beacon.Sub-mucosal neuroablation probe 35 comprises surgical probe shaft 36,and surgical hand piece 37. Surgical probe shaft 36 is a hollowelongated structure with a distal end 38, and a proximal end 39.Surgical hand piece 37 is disposed at the proximal end 39 of surgicalprobe shaft 36. Surgical probe shaft 36 comprises rigid segment 43,which is proximal to flexible segment 42. A neuroablation implement 41is disposed near the distal end of flexible segment 42, as shown.Associated with the neuroablation implement 41 is expandable structure40. Neuroablation implement 41 may be configured for sub-mucosalneuroablation by at least one of the following neuroablation means:neuroablation by tissue freezing mechanism, neuroablation by tissueheating and coagulation mechanism, or neuroablation by sub-mucosaldelivery of a neurolytic solution. The neurolytic agent may be aneurotoxin, a sympatholytic, or a sclerosing agent. For embodiments ofthe invention that use tissue freezing as a neuroablation mechanism,neuroablation implement 41 represents a liquid cryogen evaporationchamber, or a gas expansion chamber configured with a Joule-Thompsonmechanism. For embodiments of the invention that utilize tissue heatingand coagulation as a neuroablation mechanism, implement 41 may representa radiofrequency (RF) energy heating element, a microwave energy heatingelement, an ultrasonic energy heating element, and optical energyheating element or resistive heating element. For embodiments of theinvention that utilize sub-mucosal delivery of a neurolytic solution,neuroablation implement 41 may comprise a distal aperture of a fluidchannel configured for sub-mucosal delivery of a neurolytic solution.

Surgical hand piece 37 comprises pistol grip 44, neuroablation actuatortrigger 45, expandable structure inflation/deflation control lever 46,neuroablation parameter(1) control knob 47, neuroablation parameter(2)control knob 48, finger grips 50, finger grip barrel 49, andneuroablation actuator button 52. Surgical hand piece 37 may beconfigured to be held like a piston by the surgeon using pistol grip 44,or the surgeon may hold surgical hand piece 37 like a writing utensilusing finger grips 50, with finger grip barrel 49 residing between thethumb and index finger of the surgeon. Surgical hand piece 37 may beconfigured with neuroablation actuators comprising pistol triggerneuroablation actuator 45, which may be used to actuate and terminate aneuroablation when the surgeon holds the surgical probe 35 using pistolgrip 44. Neuroablation actuator button 52 may be used to actuate andterminate a neuroablation when the surgeon holds surgical probe 35 byfinger grips 50.

For embodiments of the invention that utilize tissue freezing as aneuroablation mechanism, surgical hand piece 37 may comprise a liquidcryogen reservoir, not shown, that may be supplied from the factory withliquid cryogen and configured for a single patient use. Alternatively,surgical hand piece 37 may be configured for use with a user replaceableliquid cryogen reservoir in the form of a cartridge. Liquid cryogencartridges are readily commercially available from many sources.Neuroablation actuator trigger 45 and neuroablation actuator button maybe configured as cryogen control actuators. Neuroablation parameter(1)control knob 47 and neuroablation parameter(2) control knob 48 may beconfigured to control at least one of the following neuroablationparameters: Cryogen flow rate, cryogen flow time, tissue set pointtemperature, evaporation set point temperature, or an active re-warmingtemperature or power.

For embodiments that utilize tissue heating and coagulation as aneuroablation mechanism, hand piece 37 may comprise an energy generatordisposed within, which may be an RF energy generator, a microwave energygenerator, an ultrasonic energy generator, an optical energy generator,or an energy generator configured for resistive heating. Neuroablationactuator trigger 45 and neuroablation actuator button 52 may beconfigured to turn an energy generator on and off. Neuroablationparameter(1) control knob 47, and neuroablation parameter(2) controlknob 48 may be configured to control at least one of the followingneuroablation parameters: A set point tissue temperature, a heatingpower, a heating current, a heating voltage, or a heating time.

There are embodiments where neuroablation actuator trigger 45,neuroablation actuator button 52, neuroablation parameter(1) controlknob 47, or neuroablation parameter(2) control knob 48 may absent.Embodiments that utilize sub-mucosal delivery of a neurolytic solutionmay not utilize these features.

Expandable structure 40 is disposed in the vicinity of distal end 38,and is proximal to neuroablation implement 41. Expandable structure 40may be fabricated from an elastomeric material such as silicone rubber,or may be fabricated from a substantially non-elastic material such asPET or polyethylene. During insertion of surgical probe shaft 36 intothe sub-mucosal space, expandable structure 40 is in an un-expandedstate. To visually identify the location of the distal end 38 of probeshaft 36 by endoscopic observation of the lateral nasal wall 14,expandable structure 40 is expanded as depicted in FIG. 3B. The expandeddiameter of expandable structure 40 is between approximately, e.g., 4 mmand 8 mm, and the axial length of expandable structure 40 is betweenapproximately, e.g., 4 mm and 8 mm. The configuration and constructionof expandable structure 40 is substantially similar to an occlusionballoon, which is a common surgical instrument. Those skilled in the artof surgical instruments and occlusion balloons are familiar with themeans for incorporating and expandable structure as described above;therefore, no further description is warranted. The interior ofexpandable structure 40 is in fluidic communication with a fluidreservoir, which may be disposed within surgical hand piece 37.Expandable structure 40 is expanded by insertion of fluid from the fluidreservoir into the interior of expandable structure 40 under pressurethrough fluid port 51. The fluid is removed from the interior ofexpandable structure 40 under suction, to return expandable structure 40to its un-expanded state. Inflation/deflation control lever 46 isconfigured to pressurize and de-pressurize the fluid reservoir withinsurgical hand piece 37. Alternatively, expandable structure 40 may beconfigured to be in fluidic communication with a fluid filled syringe,which may be used for inflation and deflation of expandable structure40.

FIG. 4A and FIG. 4B are schematic cross sectional illustrationsdepicting the distal end 38 of surgical probe shaft 36 inserted into thesurgical plane between the bone of the lateral nasal wall and the nasalmucosa. FIG. 4A depicts expandable structure 40 in its unexpanded state.FIG. 4B depicts expandable structure 40 in its expanded state, showingthe resulting lateral displacement 58 of the nasal mucosal surface 57.The lateral displacement 58 is visually detectable by endoscopicobservation, which provides the surgeon with the location of distal end38 of surgical probe shaft 36 relative to the nasal anatomy.

FIG. 5A, FIG. 5B and FIG. 5C are cross sectional illustrations depictingthe serial insertion of the distal end 18 of surgical probe shaft 16into the sub-mucosal space 56 (FIG. 5A), and the advancement of distalend 18 of surgical probe shaft 16 towards the target posterior nasalnerve 8 (FIG. 5B), and the positioning of neuroablation implement 21into position for neuroablation immediately proximate to targetposterior nasal nerve 8 (FIG. 5C). FIG. 5A depicts distal end 18inserted into the nasal mucosal from an insertion point that is anteriorto the sphenopalatine foramen 4 and posterior nasal nerve 8. FIG. 5Adepicts the insertion of surgical probe shaft 16 to the point whereneuroablation implement 21 and optical beacon 20 are in contact with thebone 55 of the lateral nasal wall 14. FIG. 5B depicts the furtherinsertion of surgical probe shaft 16 towards the target posterior nasalnerve 8. The distal end 18 of probe shaft 16 follows the surgical plane71 defined by the facial boundary between the mucosa 56 and the bone ofthe lateral nasal wall 14 as shown. The light 30 from optical beacon 20trans-illuminates the mucosa 56 and can be visualized by endoscopicobservation of the mucosal surface 57 providing the surgeon with aprecise indication of the position of the distal end 18 of surgicalprobe 16 relative to the surrounding anatomical landmarks. The shape ofdistal end 18, and the flex characteristics of flexible segment 22 ofprobe shaft 16 are optimized to bluntly dissect along surgical plane 71as distal end is advanced towards target posterior nasal nerve 8, asshown.

FIG. 5C depicts distal end 18 positioned immediately proximate to targetposterior nasal nerve 8, which is co-sheathed with the sphenopalatineartery and vein. As the optical beacon 20 approaches the targetposterior nasal nerve 8, the trans-illumination dims as the green light30 is strongly absorbed by the hemoglobin in the blood flowing throughthe sphenopalatine artery and vein. In addition, as the optical beacon20 approaches the target posterior nasal nerve 8, a portion of the light30 escapes down the sphenopalatine foramen, instead of reflecting offthe bone 55 and towards the mucosal surface 57, this contributes to thedimming of the trans-illumination. The surgeon may determine that thedistal end 18, and neuroablation implement 21 is in an optimal positionfor sub-mucosal neuroablation at the location of maximal dimming of thetrans-illumination. The ideal zone of effect of neuroablation 69 isdepicted as a sphere. The means of neuroablation may be a tissuefreezing mechanism, a tissue heating and coagulation mechanism, or bysub-mucosal delivery of a neurolytic solution proximate to the targetposterior nasal nerve 8 or its branches 10, 11 or 12. In addition,distal end 18 may comprise an ultrasonic Doppler flow sensor, or anoptical Doppler flow sensor to locate the sphenopalatine artery and veinin order to position distal end 18 into an optimal position forsub-mucosal neuroablation.

While the treatment is performed upon the targeted tissue with theneuroablation mechanism, the mucosa surrounding the region is ideallypreserved. Hence, the neuroablation treatment may be controlled,modulated, or limited so as to treat the surrounding tissue immediatelyaround the neuroablation implement 21 to a thickness of, e.g., 50-1000microns.

Optionally, a thermally conductive substance such as a gel G may beplaced upon the mucosal surface 57 in proximity to the probe shaft wherethe tissue is treated. The gel G may help to maintain the mucosaltemperature near body temperature while the treatment occurs so as topreserve the mucosa. Moreover, the gel G may be deposited prior to orduring the treatment by various mechanisms. Additionally, while themucosal surface 57 directly above the treatment region may be coatedwith the gel G, other regions of the mucosal surface 57 may also becoated with the gel G as well to facilitate the dissipation of any heattransfer. Gel G can be preheated when a freezing method of ablation isused or pre cooled when a heating method of ablation is used, to moreeffectively protect the mucosal tissue.

In yet another embodiment of the neuroablation probe 15, FIG. 5Dillustrates a probe 15 having a flexible segment 22 which issufficiently flexible to coil upon itself when deployed within thetissue. FIG. 5E shows a top view of the flexible segment 22 which may becoiled beneath the mucosal tissue so as to form a planar structure. Theneuroablation implement 21 disposed near the distal end of flexiblesegment 22 may still be positioned in proximity to the targeted tissuebut because of the formed planar configuration, the tissue immediatelyabove and below the plane may be appropriate treated.

FIG. 6A is a schematic illustration of the distal end 74 of surgicalprobe shaft 75 of sub-mucosal cryoablation probe 73. Sub-mucosalcryoablation probe 73 utilizes a tissue freezing neuroablationmechanism. FIG. 6B is a cross sectional schematic illustration ofsub-mucosal cryoablation probe 73 taken at section “A-A” from FIG. 6A.Cryogen evaporation chamber 76 is disposed on the distal end 74 offlexible segment 90 of surgical probe shaft 75, as shown. Cryogenevaporation chamber 76 comprises evaporator cylinder 91, which is ahollow cylindrical structure that may be fabricated from stainless steelhypodermic tubing, which defines the lateral wall of evaporation chamber76, and evaporation chamber cap 86, which defines the distal end ofevaporation chamber 76. The proximal end of cryogen evaporation chamber76 is open and in sealed fluidic communication with cryogen exhaust gaspathway 78, which is the central lumen of surgical probe shaft 75.Optical diffuser 80 is disposed at the distal tip of evaporation chambercap 86 as shown. The distal end of optical fiber 79 is in an opticalarrangement with optical diffuser 80 at its distal end, and the sourceof illumination at its proximal end, which may reside within thesurgical hand piece, not shown. Optical diffuser 80 is configured todiffuse emitted light in a substantially uniform manner over a sphericalarch between approximately 90 to 120 degrees. Cryogen delivery tube 77is in fluidic communication with a liquid cryogen source, which may bedisposed in the surgical hand piece, and the cryogen evaporation chamber76, through liquid cryogen metering ports 87. Metering ports 87 aresmall fenestrations in the wall of liquid cryogen delivery tube 77, andare configured in size and quantity to meter liquid cryogen into theevaporation chamber 76 in a manner that ensures that the rate of liquidcryogen evaporation is sufficient to lower the temperature of the tissuefreezing surface 83 sufficiently to freeze a large enough volume oftissue for effective neuroablation. The interior of liquid cryogenevaporation chamber 76 may comprise a liquid absorbing materialconfigured to retain cryogen when in its liquid state, and releasecryogen in its gaseous state to prevent liquid cryogen from exhaustingdown the cryogen gas exhaust path 78. Flexible segment 90 of probe shaft75 comprises a tightly wound metal wire coil 81 with a major dimension84 between approximately, e.g., 0.25 mm and 1.5 mm, and a minordimension 85 between approximately, e.g., 0.10 mm and 0.40 mm. Wire coil81 is wrapped with a polymeric liner 82 the entire length of flexiblesegment 90 to maintain wire coil 81 integrity, and to provide a fluidtight wall for the entire length of flexible segment 90. Optical fiber79 may reside in a coaxial arrangement with liquid cryogen delivery tube77 as shown, or may reside within cryogen gas exhaust path 78.

FIG. 7A and FIG. 7B are schematic illustrations of the distal end 97 ofbipolar RF sub-mucosal neuroablation probe 95, which is configured forsub-mucosal neuroablation by tissue heating and coagulation mechanism.Coagulation RF electrode 100 is disposed on the distal end 97 andsurrounds optical beacon 99. Neutral RF electrode 102 is disposedproximal to coagulation RF electrode 100, and is electrically isolatedfrom coagulation RF electrode 100 by electrical isolator 101.Coagulation RF electrode 100 is connected to one pole of an RF energygenerator, not shown, with a wire, where the RF energy generator may bedisposed within the surgical hand piece, not shown. Neutral RF electrode102 is connected to the second pole of the RF generator with a wire. Thesurface area of neutral RF electrode 102 is between approximately, e.g.,3 to 10 times greater than the surface area of the coagulation RFelectrode 100. During use RF current flows between coagulation RFelectrode 100, and Neutral RF electrode 102, through the tissuecontacting the two electrodes 100 and 102. The difference in surfacearea between the two electrodes 100 and 102 results in a substantiallyhigher RF current density at the surface of the coagulation RF electrode100, resulting in a concentration of joule effect heating at the surfaceof the coagulation RF electrode 100. The level of Joule effect heatingat the surface of the neutral RF 102 electrode is insufficient to raisethe temperature of the contacting tissue to level that result in thermalinjury. Other embodiments that utilize a tissue heating and coagulationas a neuroablation mechanism remain within the scope of this invention.

FIG. 8A and FIG. 8B are schematic illustrations of the distal end 106 ofsub-mucosal neurolytic solution delivery (SMNSD) probe 105, which isconfigured for sub-mucosal delivery of a neurolytic solution for thetreatment of rhinitis. SMNSD probe 105 comprises surgical probe shaft107, and a surgical probe hand piece not shown. Surgical probe shaft 107comprises distal end 106 and a proximal end not shown. Distal tip 111 isdisposed on the distal end of flexible segment 108. Optical beacon 109is disposed at the distal end of distal tip 111 as shown and previouslydescribed. Distal tip 111 comprises at least one fluid port 110 disposedin the vicinity of the distal end 106 in an arraignment that may besimilar to that depicted. At least one fluid port 110 is in fluidiccommunication with a reservoir, not shown comprising a neurolyticsolution. The reservoir may be disposed on or within the surgical handpiece, or may comprise a syringe in fluidic communication with the handpiece and fluid port(s) 110. The surgical hand piece may comprise ameans for transferring a portion of the neurolytic solution from thereservoir into the sub-mucosal tissue space about distal tip 111 duringuse. The neurolytic solution may comprise a neurotoxic agent, asympatholytic agent, or a sclerosing agent. A neurotoxic agent may bebotulinum toxin, β-Bunarotoxin, tetnus toxin, α-Latrotoxin or anotherneurotoxin. A sympatholytic agent may be Guanethidine, Guanacline,Bretylium Tosylate, or another sympatholytic agent. A sclerosing agentmay be ethanol, phenol, a hypertonic solution or another sclerosingagent. The neurolytic solution may have a low viscosity similar towater, or neurolytic solution may have a high viscosity and be in theform of a gel. The gel functions to prevent migration of the neurolyticsolution from the target space.

FIG. 9 is a cross sectional schematic illustration of the distal end ofgeneric sub-mucosal neuroablation probe 115 comprising a neuroablationimplement comprising an expandable evaporation chamber 120 configuredfor tissue freezing, which also functions as an expandable endoscopicvisual aid. Depicted is the distal end of probe shaft 116, wire coilstructure 117, end cap 118, liquid cryogen supply line 119, expandablemembranous structure 120, in its expanded state, ostium 121, adhesivebond 122 between ostium 121 and probe shaft 116, cryogen gas exhaustvent 123, exhaust gas flow path 124, pressure bulkhead 125, liquidcryogen evaporation chamber 126, and liquid cryogen 127. Liquid cryogenchamber 128 is defined by spring coil 117, end cap 118, and pressurebulkhead 125. Liquid cryogen 127 enters liquid cryogen chamber 128through liquid cryogen supply line 119, and through liquid cryogen ports129. Wire coil 117 is configured to meter liquid cryogen 127 from liquidcryogen chamber 128 into liquid cryogen evaporation chamber 126 in amanner that sprays liquid cryogen 127 in the direction of interiorsurface 130 of expandable membranous structure 120 so that the liquidcryogen rapidly evaporates upon contact with inner surface 130. Aperforated polymeric liner, not shown, disposed upon wire coil 117 maybe used to provide proper metering and spatial distribution of liquidcryogen 127. Sub-mucosal neuroablation probe 115 is configured soexpandable membranous structure 120 expands to a predetermined size andshape in response to liquid cryogen evaporation within. Sub-mucosalneuroablation probe 115 is also configured with a means for the user toexpand the membranous structure 120 independently from liquid cryogen127 evaporation in a manner that allows the expandable membranousstructure 120 to function as an endoscopic visualization aid aspreviously described. Sub-mucosal neuroablation probe 115 is configuredsuch that the outer surface of expandable membranous structure 120 willbe between approximately, e.g., −20 Deg. C. to −50 Deg. C. duringcryogen 127 evaporation within. Expandable membranous structure 120 is ahollow bulbous structure in its expanded state, and comprises a singleostium 121 configured for adhesive bonding to distal end of probe shaft116 using adhesive bond 122. Cryogen exhaust vent 123 comprises at leastone fenestration in distal end of probe shaft 116, which is in fluidiccommunication with a proximal vent port, not shown, and the room. Apressure relief valve, not shown, may be disposed in the fluid pathbetween the interior of expandable membranous structure 120 and the roomto control the pressure within expandable membranous structure 120, andthe degree of expansion during liquid cryogen 127 evaporation.

The applications of the disclosed invention discussed above are notlimited to certain treatments or regions of the body, but may includeany number of other treatments and areas of the body. Modifications ofthe above-described methods and devices for carrying out the invention,and variations of aspects of the invention that are obvious to those ofskill in the arts are intended to be within the scope of thisdisclosure. Moreover, various combinations of aspects between examplesare also contemplated and are considered to be within the scope of thisdisclosure as well.

1. A cryo-surgical probe having a position indicator for treatingrhinitis of a patient, the cryo-surgical probe comprising: a surgicalprobe shaft having an elongated hollow structure with a proximal end anda distal end, wherein the surgical probe shaft is sized for insertioninto and advancement within a sub-mucosal space of a lateral nasal wallfrom within a nasal cavity of a patient; a handle coupled to theproximal end to facilitate handling and positioning of the surgicalprobe shaft within the nasal cavity; a position indicator disposed inthe vicinity of the distal end of the surgical probe shaft to facilitatevisual tracking of a position of the distal end of the surgical probeshaft within the sub-mucosal space of the lateral nasal wall; and acryo-ablation element coupled to the distal end of the surgical probeshaft configured to cryogenically ablate at least one nasal nerve toreduce at least one symptom of rhinitis.